Bilateral diffuse lamellar keratitis following bilateral simultaneous versus sequential laser in situ keratomileusis.

AIM: To determine the difference in the incidence of bilateral diffuse lamellar keratitis (DLK) in patients undergoing simultaneous versus sequential laser in situ keratomileusis (LASIK) as an indication of intrinsic risk for inflammation. METHODS: A retrospective non-comparative case series of 1632 eyes that had undergone bilateral, simultaneous or sequential LASIK between April 1998 and February 2001 at a university based refractive centre by three surgeons. All cases that developed clinically evident DLK were identified and reviewed. In order to identify isolated cases and exclude those caused by environmental factors, when more than one patient in a given session developed DLK, the session was excluded. The main outcome measure was the incidence of unilateral and bilateral isolated, non-epidemic DLK. RESULTS: Of 1632 eyes, 126 eyes (7.7%) of 107 patients developed at least grade 1 DLK. In six operating sessions, DLK was observed in more than one patient per session, and on this basis 13 patients were excluded. 16 of the 94 remaining patients developed DLK in both eyes (17.0%). Six of 41 patients (14.6%) in the simultaneous group, versus 10 of 53 patients (18.9%) in the sequential group developed bilateral DLK (p >0.5). CONCLUSION: In isolated, non-epidemic bilateral DLK, a similar incidence was observed regardless of whether the surgery was simultaneous or sequential, suggesting an underlying intrinsic cause for DLK.

Two-year outcomes of intrastromal corneal ring segments for the correction of myopia.

OBJECTIVE: To evaluate the safety and efficacy of Intrastromal Corneal Ring Segments (ICRS) for the correction of myopia. DESIGN: Nonrandomized, comparative trial. PARTICIPANTS: Patients enrolled in the United States Food and Drug Administration phase II and phase III clinical trials of the ICRS had best spectacle-corrected visual acuity (BSCVA) of 20/20 or better, myopia of -1.00 to -3.50 diopters (D), and a cylindrical correction of 1.00 D or less as measured by manifest refraction. INTERVENTION: Surgical correction of myopia with an ICRS. MAIN OUTCOME MEASURES: Efficacy was assessed by predictability of refractive outcome (deviation from predicted cycloplegic refraction spherical equivalent), stability of refractive effect, and postoperative uncorrected visual acuity. Safety was assessed by adverse events, maintenance or loss of preoperative BSCVA, and induced manifest refraction cylinder. RESULTS: Four hundred fifty-two patients were enrolled at 11 investigational sites in both studies. Of the 454 surgical attempts, 449 received an ICRS in one eye (0.25, 0.30, and 0.35 mm in 148, 151, and 150 eyes, respectively). First surgeries were attempted in 452 patients. An ICRS was successfully implanted in 447 initial eyes, and 5 surgeries were discontinued. Of the five discontinued surgeries, three patients subsequently exited from the study, and two patients went on to have the ICRS implanted in the second eye, bringing the total number of successful implants to 449 patient eyes. Month 24 postoperative follow-up was completed on 358 patients (80%). At month 24, 328 of 354 eyes (93%) were within +/-1.00 D of predicted refractive outcome. Refraction changed by 1 D or less in 97% of eyes (421/435) between 3 and 6 months after implantation and in 99% (343/348) between months 18 and 24. Before surgery, 87% of eyes (390/448) saw worse than 20/40 uncorrected; 24 months after surgery, 55% of eyes (196/358) saw 20/16 or better, 76% (271/358) saw 20/20 or better, and 97% (346/358) saw 20/40 or better. Although two eyes (2/358; 0.5%) lost two or more lines of BSCVA at 24 months; visual acuity in both was 20/20 or better. Intraoperative complications included anterior corneal surface perforation (three eyes) and anterior chamber perforations (two eyes, one during an attempted exchange procedure); all healed spontaneously without suturing and without loss of BSCVA. The ICRS was repositioned in five eyes to increase correction. Postoperative complications in one eye each were infectious keratitis, shallow segment placement, and loss of two lines of BSCVA at two or more consecutive examinations (subsequently regained). CONCLUSIONS: The ICRS safely, predictably, and effectively reduced or eliminated myopia of -1.00 to -3.50 D. The refractive effect was stable over time.

Intrastomal corneal ring segments: reversibility of refractive effect.

PURPOSE: To evaluate the reversibility of refractive effect following removal of the ICRS (intrastromal corneal ring segments; Intacs). METHODS: Data from 34 eyes from which ICRS were removed during United States FDA Phase II and III clinical trials were evaluated with regard to segment size, loss or change of best spectacle-corrected visual acuity (BSCVA), any change of uncorrected visual acuity (UCVA), manifest spherical equivalent refraction, manifest cylinder refraction, stability of manifest cylinder refraction, and subjective visual symptoms. RESULTS: Out of 725 initial or contralateral eyes placed with the ICRS during Phase II and III clinical trials, segments were removed from 34 eyes (4.7%). Other than one (1/725, 0.1%) safety related ICRS removal, 30/725 (4.1%) were due to visual symptoms. ICRS removal was accomplished under topical anesthesia without complications in all eyes. The mean length of time the segments remained in the cornea after initial surgery was 10.3 +/- 5.4 months. At 3 months after ICRS removal, 21 eyes had monitored data available and were within +/-1 line or 10 letters of their preoperative BSCVA. Twenty eyes (20/21, 95%) returned to within +/-1.00 D of their preoperative manifest spherical equivalent refraction. All eyes had a stable refraction at the 3-month examination after removal, and a manifest spherical equivalent refraction within +/-1.00 D of their 1-month examination after removal. Nineteen eyes (19/21, 90%) returned to within +/-2 lines and 16 eyes (16/21, 76%) returned to within +/-1 line of preoperative UCVA. CONCLUSION: The ICRS (Intacs) was easily and safely removed, and eyes returned to preoperative refractive status within 3 months.

Initial two years of experience with the AAO National Eyecare Outcomes Network (NEON) cataract surgery database.

PURPOSE: To report the results of the first 2 years of experience with an American Academy of Ophthalmology (AAO) cataract surgery registry; to compare patient characteristics, operative procedures, and patient outcomes observed in the registry to those observed in the Cataract PORT study; and to discuss the current shortcomings and potential benefits of a national cataract surgery registry. DESIGN: Observational study of episodes of cataract surgery reported by a self-selected sample of 249 ophthalmologists. PARTICIPANTS: Seven thousand six hundred twenty-six patients undergoing cataract surgery during 1996 and 1997. METHODS: Beginning in January 1996, participation in the AAO cataract surgery registry was offered to all ophthalmologists. Participants could use software or paper data collection forms to submit a common set of data regarding patients' demographics, preoperative ophthalmologic history, physical examination and test results, functional status and symptoms, intraoperative procedures and events, and postoperative outcomes for all patients undergoing first or second eye cataract surgery. Data were transmitted to a central database, where they were aggregated and analyzed. Findings were compared with those observed in the Cataract PORT study, which was conducted in 1991 and 1992. RESULTS: Between January 1, 1996, and February 28, 1998, 249 ophthalmologists submitted data on at least one patient who underwent cataract surgery. A total of 7626 patients undergoing first or second eye surgery were enrolled, with all preoperative, intraoperative, and postoperative data forms submitted for 3342 patients (44%). The preoperative characteristics of patients reported to National Eyecare Outcomes Network (NEON) were similar to those of patients enrolled in the Cataract PORT study except for a higher reported prevalence of ocular comorbidity in NEON patients. Use of retrobulbar anesthesia was reported far less commonly, and use of topical anesthesia, phacoemulsification, and foldable intraocular lenses was reported far more often for NEON than for Cataract PORT study patients. Patient outcomes reported to NEON were similar to those observed in the Cataract PORT study. MAIN OUTCOME MEASURES: Visual acuity, VF-14, Cataract Symptom Score, surgical complications. CONCLUSIONS: During the first 2 years of NEON, ophthalmologist participation in the NEON cataract surgery database was low and consisted of a self-selected and likely nonrepresentative sample of ophthalmologists. The representativeness of patients for whom data were reported is unknown. In addition, complete data were submitted on only a minority of patients who were enrolled. Even so, the preoperative characteristics of patients on whom data were submitted to NEON were similar to those of patients enrolled in the Cataract PORT study. The initial experience with NEON demonstrates that it is technically possible to collect clinical data from, and report aggregated results to, practicing clinicians' offices. In addition, at least some practicing clinicians are willing to spend the time required to participate in the NEON registry. The NEON cataract surgery database thus has the potential to provide a practical means for tracking practice patterns and patient outcomes in real time. If a representative sample of physicians was willing to contribute data systematically and accurately over time, initiatives such as NEON could provide a means for professional societies and physicians to play a leadership role in defining and monitoring quality of care.

Conjunctivitis.

Conjunctivitis refers to any inflammatory condition of the membrane that lines the eyelids and covers the exposed surface of the sclera. It is the most common cause of "red eye". The etiology can usually be determined by a careful history and an ocular examination, but culture is occasionally necessary to establish the diagnosis or to guide therapy. Conjunctivitis is commonly caused by bacteria and viruses. Neisseria infection should be suspected when severe, bilateral, purulent conjunctivitis is present in a sexually active adult or in a neonate three to five days postpartum. Conjunctivitis caused by Chlamydia trachomatis or Neisseria gonorrhoeae requires aggressive antibiotic therapy, but conjunctivitis due to other bacteria is usually self-limited. Chronic conjunctivitis is usually associated with blepharitis, recurrent styes or meibomianitis. Treatment requires good eyelid hygiene and the application of topical antibiotics as determined by culture. Allergic conjunctivitis is distinguished by severe itching and allergen exposure. This condition is generally treated with topical antihistamines, mast-cell stabilizers or anti-inflammatory agents.

Minocycline-induced scleral, dental, and dermal pigmentation.

PURPOSE: To report a case of scleral discoloration secondary to minocycline therapy. METHOD: Case report of a patient referred to a university-based cornea and external disease clinic. RESULTS: The patient had been treated with oral minocycline therapy for adult facial acne for 12 years when she began to develop bilateral blue-gray discoloration of the sclera as well as of the teeth, hard palate, ears, nail beds, and skin. CONCLUSIONS: Chronic systemic minocycline therapy may induce scleral pigmentary changes. The mechanism of discoloration and the long-term natural history upon cessation of minocycline are unclear.

Informed consent in refractive surgery.

The informed consent process represents a key component in providing the highest quality of care for our patients and minimizing liability risk. Patients undergoing refractive surgery have high expectations for an excellent outcome and may become easily dissatisfied and upset if this is not achieved. Careful attention by the surgeon and supporting staff to educate the patient in a thorough and supportive fashion is paramount to this process. Breakdown in communication between physicians and patients combined with a poor outcome and feelings of mistrust often leads patients to consider malpractice litigation. The importance of understanding the key components and principles of the informed consent process cannot be over-emphasized and are presented in detail in this review.

Liability issues associated with PRK and the excimer laser.

Given the elective nature of photorefractive keratectomy (PRK), the high expectations of patients, and misconceptions of the general public about refractive surgery, the use of the excimer laser for PRK opens the door to new liability risks for ophthalmologists and, in the comanagement environment, referring optometrists. The authors discuss informed consent, marketing, comanagement, and off-label use guidelines and protocols to help protect ophthalmologists against claims and better defend those that might arise.

Prospective trial of daily and extended wear disposable contact lenses.

PURPOSE: The current study prospectively evaluates the response to daily and extended wear of disposable lenses with each patient acting as his/her own control. This paradigm allowed for elimination of individual variation as a confounding factor, as well as determining whether an intrinsic factor, other than lens wear, predisposed patients to complications. METHODS: One hundred thirty-four patients were randomly assigned to contralateral daily wear (DW) or extended wear (EW) with Acuvue lenses for 1 year. All lenses were disposed of on a weekly basis. Bilateral bacteriology of lids, conjunctivae, lenses, and fingers was carried out on those patients presenting with complications. RESULTS: The results after 1 year indicate a higher incidence of complications in the EW eye (peripheral infiltrative keratopathy, 12%; corneal striae, 3%). No significant clinical complications occurred in the DW eye. Microbiological cultures did not reveal any significant difference between those eyes with keratopathy and those of controls. The most common pathogen was Staphyloccocus epidermidis. No gram-negative organisms grew from any of the culture sites. CONCLUSIONS: The results of this study indicate that extended wearing schedules, and not the lens entity, predispose the patient to a higher risk of keratopathy with disposable contact lenses. No microbiological association with the adverse events could be determined, and no intrinsic patient factor could be demonstrated that would predict the likelihood of complications.

Aspergillus endophthalmitis after sutureless cataract surgery.

PURPOSE: We studied a case of Aspergillus endophthalmitis after sutureless cataract surgery. METHODS: A patient underwent sutureless phacoemulsification complicated by a posterior capsular tear. She subsequently developed Aspergillus endophthalmitis. Amphotericin B was injected intravitreally at the time of repeat pars plana vitrectomy. RESULTS: The eye was enucleated because of pain and poor response to treatment. CONCLUSIONS: We recommend suturing the wound in any eye that has experienced a complication of surgery.

Topical and subcutaneous alpha-interferon fails to suppress corneal neovascularization.

Corneal neovascularization is a potentially blinding complication of a variety of corneal disorders. alpha-Interferon has been shown to inhibit endothelial cell migration and proliferation. It has been used successfully in the treatment of pediatric pulmonary hemangioma and hairy cell leukemia. This study was undertaken to evaluate the effect of topical and subcutaneous (s.c.) alpha-interferon on corneal neovascularization. Corneal neovascularization was induced in 40 male New Zealand white rabbits by placing silk sutures (7.0) bilaterally in each rabbit eye at the 3 and 9 o'clock positions of the cornea, 3 mm from the limbus. Animals were randomized into two main treatment groups for topical (group 1) and s.c. (group 2) administration of interferon. Group 1 (n = 24) was then randomized into four subgroups and treated daily with topical doses of (a) rabbit specific alpha-interferon; (b) alpha-interferon plus 1% prednisolone acetate; (c) 1% prednisolone acetate; and (d) buffered phosphate control. Group 2 (n = 16) was randomized into two subgroups that received s.c. injections every other day of (a) alpha-interferon and (b) phosphate buffer. Rate of corneal neovascularization was documented photographically, with the end-point being the arrival of vessels at the suture for each group. The results of this study indicated that at the concentration and dosing regimens we used, neither topical nor s.c. alpha-interferon inhibits the rate of corneal vascular growth significantly when compared with our phosphate buffered solution control group (p = 0.88 and p = 0.84, respectively). Prednisolone acetate appeared to be the most effective in inhibiting corneal neovascularization (p = 0.003).(ABSTRACT TRUNCATED AT 250 WORDS)

Effect of diclofenac sodium (Voltaren) on hypoxia-induced corneal edema in humans.

We evaluated the effect of diclofenac sodium (Voltaren) drops on patients with hypoxia-induced corneal edema. Thirty age- and sex-matched subjects were randomly assigned to one of three groups. Members of each group received masked solutions of either Voltaren, Voltaren vehicle, or a non-preserved lubricant (Cellufresh) every 6 hours for 24 hours and then hourly for 2 hours immediately prior to inducing corneal edema in the experimental eye. Bilateral ultrasonic pachymetry was performed prior to applying a thick contact lens and light patch on the experimental eye of all subjects for 3 hours. The fellow eye served as the control. Following lens removal, bilateral corneal thickness was measured every 30 minutes. The percentage change in corneal swelling for each subject and group was calculated. The findings were also normalized to the control eye to minimize diurnal and individual variability. The results were plotted both as percentage change from hour 0 and percentage change normalized to the control eye. Corneal swelling ranged from 9-11% in all 3 groups, with recovery at 2-3 hours. No significant difference was found among the three groups (P > 0.05, ANOVA). There was a slight trend toward reduced thickness in the Cellufresh group, but this was not statistically significant. Voltaren does not appear to have an effect on the hypoxia-induced corneal edema associated with the production of arachidonic acid pathway metabolites.

Risk management issues in radial keratotomy surgery.

In this article, reprinted from Ophthalmic Risk Management Digest, the bases for radial keratotomy-related claims and guidelines for avoiding such claims are discussed. In most lawsuits, it is not the procedure itself that is on trial, but the use of unusual technique, improper execution, or inadequacy of informed consent.

Intra-abdominal desmoplastic small round cell tumour.

Intra-abdominal desmoplastic small round cell tumour is a rare tumour which has only recently been described. It demonstrates epithelial, mesenchymal and neural features and has an aggressive clinical course. We report a case of a 15 year old male with this tumour who, after debulking surgery and chemotherapy, relapsed with disease 1 month later. After further debulking surgery, extensive chemotherapy and bone marrow transplantation he relapsed with disease 5 months later and died. Total survival was 20 months.

Microbial changes in the ocular environment with contact lens wear.

A group of 30 subjects, each fit with a single disposable or non-disposable soft contact lens, was further randomized to a daily wear or extended wear schedule to determine the effect of lens wear on the normal conjunctival flora. Cultures of the subjects' inferior cul-de-sacs were taken at baseline before any lens wear and after one week of lens wear. Additionally, each subjects' lens was removed in a sterile manner and cultured at the end of the one week wear period. In all subjects, the fellow eye was used as a control. There were no statistically significant differences with respect to bacterial culture results between experimental and control eyes. Also, there were no significant differences between the pre- and post-lens wear groups. And no significant differences were found when the larger groups were broken down into different wear schedules and lens types and compared. The results of this study suggest that the ocular flora is not markedly changed after one week of contact lens wear. Also raised is the question of whether an altered ocular flora is an etiologic factor in the development of infectious keratitis in contact lens wearers.

Hypotony and corneal edema secondary to patching in normal eyes.

Over the past decade investigators have used patching when studying corneal response to eye lid closure. In these studies, corneal edema was thought to be secondary to hypoxia, and the results were used to predict corneal response to contact lens wear. None of these studies have measured or controlled the intraocular pressure (IOP) during eye patching. Reports in the literature indicate that hypotonous and hypertensive events may induce corneal edema. In order to evaluate the IOP and corresponding corneal changes, measurements were made on subjects with patched eyes. Thirty subjects were unilaterally patched and randomized into tight and light patch groups to maintain complete lid closure for 4 h. Measurements of IOP and corneal thickness (CT) were made at baseline and at hourly intervals. The contralateral eye served as the control for each subject. Our results indicate a significant decrease in IOP and a corresponding increase in CT in the tight patched group as compared to the light patch group, and baseline controls. These results suggest that the corneal edema which results from patching of the eye may be due to hypotony, or a combination of factors affecting corneal function, rather than hypoxia.

Concurrent cisplatin, infusional fluorouracil, and conventionally fractionated radiation therapy in head and neck cancer: dose-limiting mucosal toxicity.

After a preliminary dose-finding study involving 12 patients with advanced or locally recurrent head and neck cancer, 27 patients were treated on a phase II protocol, using fluorouracil 350 mg/m2/d by continuous intravenous (IV) infusion over 5 days, followed on the sixth day by a 2-hour IV infusion of cisplatin 50 mg/m2, administered during the first and fourth weeks of radiation therapy to total doses between 60 and 64 Gy, using 2 Gy daily fractions. Eight of these 27 patients had American Joint Committee on Cancer Staging (AJCC) stage III disease, and 12 had stage IV disease. Four had recurrent disease after surgery. Three-year follow-up is now available. Twenty-one (77.8%) remitted completely following treatment, and 11 remain free of local and regional relapse at 3 years. Four have developed systemic metastases. Following successful salvage treatment in two cases, estimated determinate survival at 3 years is 64%. Acute toxicity was manageable with this regime. Eleven instances of grade 3 Radiation Therapy Oncology Group/European Organization for Research and Treatment of Cancer (RTOG/EORTC) mucositis were observed, which caused interruptions to radiotherapy in only four cases. No late sequelae have so far been recorded. It is concluded that the protocol described is tolerable but probably did not cause a greater number of locoregional "cures" than would have been expected following conventional radiotherapy alone in this group of patients. The use of infusional fluorouracil with concurrent conventionally fractionated radiation therapy and cisplatin infusion results in mucositis that limits the dose of fluorouracil to levels that are probably subtherapeutic.

Long-term changes in corneal endothelium after keratoplasty. A follow-up study.

In 1983, Abbott et al. assessed endothelial cell population and function in 100 clear corneal grafts (72 patients) that were an average of 17.4 years postkeratoplasty. The present study reports on 61 of these grafts (42 patients) followed for an additional 4-6 years. Forty-nine grafts without intercurrent complications or surgery were reexamined by specular microscopy to determine the change in endothelial population in each graft. In 10 others, the reasons for regrafting were recorded. In two cases of hereditary stromal dystrophy, stromal opacity precluded a cell count. Of the grafts studied, 49 (80%) remained clear despite a depleted and slowly decreasing endothelial population. The rate of change was independent of donor age, preoperative diagnosis, or graft longevity. Two grafts failed spontaneously, and all three grafts that had cataract surgery failed in the early postoperative period. The remaining five were regrafted to correct high astigmatism or other complications. We conclude that despite a small degree of continuous cell loss, corneal grafts have a favorable prognosis for long-term clinical stability. The remaining endothelium has a minimal functional reserve, however, resulting in a high risk of graft decompensation after additional endothelial trauma.